Label: PARODONTAX COMPLETE PROTECTION- stannous fluoride paste

  • NDC Code(s): 0135-0627-01, 0135-0627-02, 0135-0627-03, 0135-0627-04
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

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  • Active ingredient

    Stannous fluoride 0.454% (0.15%w/v fluoride ion)

  • Purposes

    Anticavity

    Antigingivitis

  • Uses

    • aids in the prevention of dental cavities.
    • helps control bleeding gums.
    • helps interfere with harmful effects of plaque associated with gingivitis.
  • Warnings

    Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks.
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older:
    • apply toothpaste onto a toothbrush.
    • brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.

    children under 2 years of age:Consult a dentist or doctor.

  • Other information

    • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
    • this product is specially formulated to help prevent staining.
    • do not store above 25ºC (77ºF)
  • Inactive ingredients

    glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

  • Questions or comments?

    Call toll-free 1-855-328-5202

    ALWAYS FOLLOW THE LABEL

  • Additional Information

    ALWAYS FOLLOW THE LABEL

    Free-Sample, not for retail sale

    Trademarks owned or licensed by GSK.

    ©2022 GSK or licensor.

    • Dist. by: GSK CH, Warren, NJ 07059. Made in Germany

    Warren, NJ 07059

  • Principal Display Panel

    DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

    parodontax

    HELPS PREVENT BLEEDING GUMS

    PURE FRESH MINT

    COMPLETE PROTECTION

    SCAN TO SAVE NOW

    NET WT 0.8 OZ (23 g)

    62000000076142

    Parodontax Complete Protection 0.8 oz (23 g)
  • INGREDIENTS AND APPEARANCE
    PARODONTAX   COMPLETE PROTECTION
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0627
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0627-021 in 1 CARTON11/01/2018
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0627-031 in 1 CARTON01/06/2020
    265.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0627-011 in 1 CARTON04/01/2020
    323 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0627-0423 g in 1 TUBE; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02211/01/2018
    Labeler - Haleon US Holdings LLC (079944263)
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